Identity
- Trade Name
- Heidelberg pH Capsule System FDA UDI
- Generic Name
- Gastrointestinal telemetric monitoring system FDA UDI
- Device Name
- The pH Capsule Calibration Kit is designed primarily for activating and calibrating the pH telemetric capsule, it includes the following: the calibration test fixture is a 10-inch square acrylic plate that contains a raised capsule holder for holding the pH capsule during calibration. The acrylic plate also has a clear acrylic block attached to it, for holding 6 test tubes. There are two large round holes in the sides of the plate: for holding the Saline and Rinse contains. There is also provision for placement of the glass Alkaline challenge container. Included with the Kit is a glass container labeled Saline, a glass container labeled Rinse and a glass container labeled NaCH03. The kit contains 6 test tubes, one spool of tether thread, solutions, a 6-inch Delrin capsule holder: for holding the pH capsule during the pH calibration procedure. FDA UDI
- Model / Reference
- Heidelberg pH Capsule Calibration Kit FDA UDI
- Description
- The pH Capsule Calibration Kit is designed primarily for activating and calibrating the pH telemetric capsule, it includes the following: the calibration test fixture is a 10-inch square acrylic plate that contains a raised capsule holder for holding the pH capsule during calibration. The acrylic plate also has a clear acrylic block attached to it, for holding 6 test tubes. There are two large round holes in the sides of the plate: for holding the Saline and Rinse contains. There is also provision for placement of the glass Alkaline challenge container. Included with the Kit is a glass container labeled Saline, a glass container labeled Rinse and a glass container labeled NaCH03. The kit contains 6 test tubes, one spool of tether thread, solutions, a 6-inch Delrin capsule holder: for holding the pH capsule during the pH calibration procedure. FDA UDI
Identifiers
- Catalog Number
- PCCK330 FDA UDI
- Primary DI / UDI-DI
- B989PCCK3300 FDA UDI
- FDA Product Code
- FFT FDA UDI
- GMDN Term
- Gastrointestinal telemetric monitoring system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.1400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Gastrointestinal telemetric monitoring system
Heidelberg pH Capsule System by Heidelberg Medical Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Heidelberg Medical Inc
Sources (1)
- FDA UDI 96d246e2-af9c-4b9c-baeb-3ccc28f83fbc 35 fields · synced Jun 6, 2026